S T AND ING ON PR INC I P L E S

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STANDING ONPRINCIPLES

C O L L E C T E D E S S A Y S

TOM L . B EAUCHAMP

12010

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Library of Congress Cataloging-in-Publication Data

Beauchamp, Tom L.

Standing on principles : collected essays / Tom L. Beauchamp.

p. ; cm.

Contains articles published previously in various sources.

Includes bibliographical references and index.

ISBN 978-0-19-973718-5

1. Bioethics. 2. Human experimentation in medicineMoral and ethical aspects. I. Title.

[DNLM: 1. BioethicsCollected Works.

2. Human ExperimentationCollected Works. WB 60 B371s 2010]

QH332.B425 2010

1740.957dc222009033282

1 3 5 7 9 8 6 4 2

Printed in the United States of America

on acid-free paper

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To

Ruth R. Faden

Partner for life and a magnificent human being in every way of being human.

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CONTENTS

Acknowledgments ix

Introduction xiii

PART I The Belmont Report and the Rise of Principles

ONE The Origins and Evolution of the Belmont Report 3

TWO Codes, Declarations, and Other Ethical Guidance for Human

Subjects Research: The Belmont Report 18

PART II Principlism and Practice

THREE The Four Principles Approach to Health Care Ethics 35

FOUR Informed Consent: Its History and Meaning 50

FIVE Who Deserves Autonomy and Whose Autonomy Deserves

Respect? 79

SIX The Concept of Paternalism in Biomedical Ethics 101

SEVEN When Hastened Death is Neither Killing nor

Letting Die 120

EIGHT The Exploitation of the Economically Disadvantaged in

Pharmaceutical Research 132

PART III Theory and Method

NINE Principles and Other Emerging Paradigms

in Bioethics 153

TEN A Defense of the Common Morality 175

ELEVEN From Morality to Common Morality 189

AlbertoRectngulo

AlbertoRectngulo

TWELVE On Eliminating the Distinction Between Applied Ethics and

Ethical Theory 211

THIRTEEN Does Ethical Theory Have a Future in Bioethics? 229

FOURTEEN The Failure of Theories of Personhood 247

FIFTEEN Looking Back and Judging Our Predecessors 261

Index 281

viii C O N T E N T S

ACKNOWLEDGMENTS

Many parts of this book are connected to my work with James Childress. Our

collaboration has been a two-way conversation, and he has been an abiding help

in stimulating my thought on several of the essays in this volume. In 1978, Jim and

I decided on the persons to whom we would dedicate the volume. On my side, I

dedicated the volume to Ruth Faden and Donald Seldin, with whom I was in

frequent conversation at the time about the embryonic but developing field of

bioethics. I chose well. Now, more than 30 years later, they remain the deepest

influences on my work on the subjects in this volume. Their personal dedication

to me and their professional facilitation of my work have been remarkable.Wayne

Davis, my department chair, deserves a similar acknowledgment for his support

over the last 20 years. Perhaps no one is a perfect chair, but Wayne seems so, and

he is a model of the honest philosopher.

Philosophers should learn from their critics, and I have had some dedicated

critics over the years on several of the subjects addressed in this volume. I

acknowledge in particular the many contributions made by John Arras, Bernard

Gert, Danner Clouser, Albert Jonsen, Ronald Lindsay, Edmund Pellegrino, and

David DeGrazia. All have offered trenchant criticisms. Other valued criticism has

come from Oliver Rauprich, Rebecca Kukla, Carson Strong, Peter Herissone-

Kelly, Avi Craimer, Frank Miller, and Robert Veatch.

Essay 1, The Origins and Evolution of the Belmont Report, and Essay 2,

Codes, Declarations, and Other Ethical Guidance for Human Subjects

Research: The Belmont Report, are centered on the years I worked for the

National Commission for the Protection of Human Subjects (19751978), some

of the most rewarding years of my life. I owe thanks to the many people who

supported me in writing for the Commission, especially the writing of Belmont.

I owe special acknowledgments to Patricia King, Michael Yesley, Donald

Seldin, Albert Jonsen, Stephen Toulmin, Robert Levine, Barbara Mishkin, and

Kenneth Ryanand, for later criticisms, Ernest Marshall. They all caused me

to rethink my ideas many times over. I am also grateful to Jay Katz, Samuel

Gorovitz, LeRoy Walters, Tris Engelhardt, Charles McCarthy, and John

Robertson for conversations and help in research during these years. For

excellent editorial advice while writing Essay 2, I recognize the contribution

made by Zeke Emanuel, Christine Grady, Robert A. Crouch, Reidar Lie, Frank

Miller, and David Wendler, as editors of the book in which the piece appeared.

Frank is owed special thanks for his efficient pursuit of my piece.

Essay 3, The Four-Principles Approach to Health Care Ethics, and Essay 9,

Principles and Other Emerging Paradigms in Bioethics, are centered on prin-

ciplism. The first of the two essays was written because Raanan Gillon persuaded

me to compose it and then helped me make it as good as it could be. Raanan has

been supportive throughout my career, and I thank him for contributions that

reach far beyond this essay. I also owe Ed Pellegrino an acknowledgment for his

many critiques of the four-principles approach, including a critique when I wrote

this essay. My thinking on these issues has been pushed forward by some stimu-

lating criticisms, published and unpublished, by Bernard Gert, Danner Clouser,

Charles Culver, John Arras, David Smith, Alasdair Campbell, John Harris, and

Dan Callahan. On the constructive side, I have enormously benefited from the

work of my colleague Henry Richardson on the subject of specification. Henry has

also been a supportive critic.

Essay 4, on Informed Consent: Its History and Meaning, appeared because

Bob Veatch persuaded me to write it and offered sound editorial advice during its

drafting. Ruth Faden stimulated me to my best ideas on informed consent, and

much of what I say here derives from our 1986 book, A History and Theory of

Informed Consent. When writing that book we received wonderful support and

criticism from Bettina Schone-Seifert and Nancy King; and we were inspired at

the time by the published work of, and personal consultation with, Jay Katz, Allen

Buchanan, Robert Levine, Alan Meisel, and Sissela Bok.

Essay 5, Who Deserves Autonomy and Whose Autonomy Deserves Respect?,

came into being because I was persuaded by James Stacey Taylor to rethink and

deepen my previous publications on autonomy. On the matters of autonomy

treated in this essay, many people have contributed to my thinking. Almost

certainly, the deepest influences have come from work with Ruth Faden and

through discussions with Joel Feinberg, who was working on his theory of

autonomy as I was first developing mine. I still today regard Feinberg as the

soundest writer on many of the subjects I address. In what seems a lifetime ago, I

had several discussions with Gerald Dworkin that helped me get my thoughts

straight on various issues about autonomy.

Essay 6, The Concept of Paternalism in Biomedical Ethics, is the final phase, I

hope, in my long history of probing the subject of paternalism. Jim Childress and I

have struggled together through the muddy conceptual issues in this area.

Although we have never come to complete agreement, Jim has convinced me to

moderate my skeptical views about soft paternalism. Jim and Ruth Faden have

been instrumental in helping me get my thoughts straight. In the early years of my

x A C K N OW L E D G M E N T S

thinking about the key problems (dating to 1975), I was influenced by Joel

Feinberg, with whom I had stimulating conversations on the subject. My work

stands in the shadow of Feinbergs seminal writing on the subject.

Essay 7, When Hastened Death Is neither Killing nor Letting Die, brings together

much ofmy thinking about physician-hastened dying. TimQuill and Peg Battin were

my editors and advisors when I wrote this essay. The compactness and directness of

the argument in this essay owe much to them. Ive learned a great deal about what to

say and not say about these issues from conversations with, and the publications of,

Dan Brock and James Rachels. I have had several public debates with Ed Pellegrino on

the topic. Ed has many times helped me understand views that I dont hold; he has a

wonderful ability to make them clear and plausible. In the early years in which my

views on these subjects were developing, I acknowledge how much I enjoyed

examining ideas through conversations with Arnold Davidson. Every philosopher

should have as much fun as Arnold and I had in those years.

Essay 8, The Exploitation of the Economically Disadvantaged in

Pharmaceutical Research, was originally written for a conference. I thank the

organizer of the conference, Denis Arnold. At the conference, I received useful

criticism from Dan Callahan, Norman Daniels, and Dan Wikler. My work on

pharmaceutical research in all its dimensions has been greatly facilitated by many

years of discussing these issues with Robert Levine. In working on the subject of

global justice and the economically disadvantaged, I have had stimulating inter-

actions with Ruth Faden, Madison Powers, and Thomas Pogge.

Essay 10, A Defense of the Common Morality, and Essay 11, From Morality

to Common Morality, are devoted to the subject of common morality. As

anyone can see by reading the second of the two essays, I owe an immense

amount to Bernard Gert, not only for his criticisms of me, but for the constructive

side of his moral theory. It is a pleasure to be able to acknowledge the influence of

his bold criticisms and his constructive theories. My essay was written for and

delivered at Dartmouth College on the occasion of Gerts retirement and 50th year

of teaching at Dartmouth. I was helped in formulating my topic by Jim Moor,

Bernies colleague at Dartmouth. Dan Brock, Ron Green, and Don Marquis gave

me stimulating criticisms during the visit to Dartmouth that helped me redraft.

More generally on the subjects of commonmorality and principlism, much in my

work has been either motivated by or improved by the work of other critics,

especially David DeGrazia, Carson Strong, and Ronald Lindsay.

Essay 12, On Eliminating the Distinction Between Applied Ethics and Ethical

Theory, and Essay 13, Does Ethical Theory Have a Future in Bioethics?, are two

of my forays into the waters of ethical theory and its limitations. The first, Essay 12,

was written long ago; it was invited by the two editors of theMonist in those years,

Eugene Freeman and John Hospers. Not much had been published on this subject

at the time, but I did greatly benefit by Gerts early work on the subject. I owe the

A C K N OW L E D G M E N T S xi

idea behind Essay 13, and criticism of it, to Jeff Kahn and Anna Mastroianni, the

two editors of the journal issue in which this essay appeared.

Essay 14, The Failure of Theories of Personhood, was first delivered as an

address in Hong Kong, where I had the good fortune to receive excellent criticism

from Gerhold Becker, John Harris, and Michael Quante. Later I received equally

helpful criticisms fromRobert Veatch andHenry Richardson when presenting the

paper at Georgetown. Throughout the period of my writing this essay, I had many

discussions about the issues with Raymond Frey.

Essay 15, Looking Back and Judging Our Predecessors, was published in the

form of an exchange between Allen Buchanan and me. Allen and I largely agreed

on every major issue, but I was given a distinct advantage when writing my essay:

Allen sent his draft first, and I was able to learn a good bit from him. I owe much

in my presentation to the structure he laid out in his essay, and both of us owe

much to the work of the Advisory Committee on Human Radiation Experiments

(ACHRE), Final Report of the Advisory Committee on Human Radiation

Experiments (New York: Oxford University Press, 1996), on whose conclusions

Allen and I were commenting. In getting straight on the history surrounding the

radiation experiments, I learned a great deal from Ruth Faden, Jonathan Moreno,

and Susan Lederer.

In the Introduction to this volume, I have supplied the names of publishers and

full bibliographical and copyright information pertaining to all original sources of

these Collected Essays.

xii A C K N OW L E D GM E N T S

I NTRODUCT ION

This volume collects essays and treatises on several subjects that I have written

over the course of 25 years. All are on philosophical and moral issues in the field of

biomedical ethics. The topics range from the historical origins of modern research

ethics to substantive issues in bioethics about moral principles and methodology.

Despite the diversity of topics, a specific unity holds the three parts of this collection

together. The unifying theme is the transparent connection of these essays to many

of the topics and chapters in Principles of Biomedical Ethics (hereafter Principles),

which I coauthored with James Childress. All readers familiar with the basic

structure of that book will see that these Collected Essays augment, develop, and

defend some of its central positions and arguments. A few essays take off in new

directions, but all have a connection to themes in Principles. I have tried to select only

essays that expand and deepen, while not duplicating, material in Principles.

This introduction explains the publishing history and content of these essays, as

well as ways in which they augment and develop the so-called principlist theory

that Childress and I developed together. The year, source, and place of publication

and an abstract of each essay are supplied.

The book is divided into three parts. The first part is entitled The Belmont

Report and the Rise of Principles. The two essays in this part explain the emerging

importance of frameworks of principles in bioethics in the mid-1970s. The

primary sources at the time of the rise of these frameworks were Principles and

the Belmont Report. The latter is a government report that I drafted for the

National Commission for the Protection of Human Subjects of Biomedical and

Behavioral Research. The history of the writing of both of these works and their

crossover influence are explained and analyzed in Part I.

The second part is entitled Principlism and Practice. This section treats

several issues about moral principles and their practical use in bioethics as well

as the nature of principlism. This word was coined by Danner Clouser and

Bernard Gert principally to refer to the theory Childress and I developed. The first

essay in this second section adopts the language of The Four-Principles

Approach, an expression originally coined by Raanan Gillon to refer to the

theory in Principles. The material in Part II develops some themes Childress and

I address in Chapters 4 through 7 of Principles (using 6th edition chapter

numbers).

The third part concentrates on questions of theory and method in ethicslong

mymajor teaching and publishing interest in bioethics. This part treats the idea that

the four-principles approach provides a theoretical framework or paradigm for

bioethics togetherwith some ideas about theory andmethod that include discussion

of the nature and role of the commonmorality. This part also probeswhether ethical

theory has a strong role to play in the future of bioethics and whether so-called

applied ethics should be sharply distinguished from general ethical theory. Two

other essays investigatewhether the concept of person has a significant role to play in

bioethics and how judgments can be made of the actions and character of persons

who lived in past decades and centuries when they embraced significantly different

moral standards. The material in the third part develops answers to various

problems that Childress and I address in Chapters 1, 2, 3, 9, and 10 of Principles.

During the preparation of this volume I have lightly edited almost all of these

essays for purposes of clarity and style. I have added content to three of the essays.

This supplementary content has in every case been drawn from other parts of my

published work. In no case have I altered the basic structure or argument found in

the original publication. I have altered a title only in the case of the fourth essay:

Informed Consent: Its History and Meaning; it was originally published under

the less specific title Informed Consent.

I also explain below precisely what I have done to alter the few essays in which

material has been added in these Collected Essays.

PART I. THE BELMONT REPORT AND THE RISE OF PRINCIPLES

Essay 1. The Origins and Evolution of the Belmont Report

Publication Data. This essay was published in Belmont Revisited: Ethical Principles

for Research with Human Subjects. Copyright 2005 by Georgetown UniversityPress. From Belmont Revisited: Ethical Principles for Research with Human Subjects,

James Childress, Eric Meslin, and Harold Shapiro, Editors, pp. 1225. Reprinted

with permission. www.press.georgetown.edu. This essay, as here slightly revised,

also draws on a small body of material in an essay I wrote in The Story of Bioethics,

also published by Georgetown University Press. Reprinted with permission.

Abstract. This 2005 article recounts my work in delineating a framework of

principles of research ethics when I was in the position of consultant philosopher

at the National Commission for the Protection of Human Subjects of Biomedical

and Behavioral Research (U.S. Congress and NIH, 197478). The article starts with

the historical context in which principles rose to prominence in biomedical ethics.

xiv I N T R O D U C T I O N

www.press.georgetown.edu

I concentrate here on research ethics. The project of creating a framework of basic

principles for all federally funded research had been mandated by a public law

enacted by the U.S. Congress. I was at work on the volume with Childress when I

accepted an assignment with the National Commission to write its Belmont

Report. I explain both the history of my drafting of this Report, how it was revised

in the course of deliberations at the National Commission, and the connection of

this drafting to my concurrent work with Childress. I discuss how the National

Commission viewed these principles as embedded in preexisting public morality

and how it regarded its set of principles as a universally valid resource for the

formulation of public and institutional policies of research ethics. I outline how

the views in Belmont express the basic structure for research ethics as it developed

in the last quarter of the twentieth century and remains today.

Essay 2. Codes, Declarations, and Other Ethical Guidance for Human Subjects

Research: The Belmont Report

Publication Data. This essay was published in The Oxford Textbook of Clinical

Research Ethics, ed. Ezekiel Emanuel, Christine Grady, Robert Crouch, Reidar Lie,

Franklin Miller, and David Wendler (New York: Oxford University Press, 2008),

149155. By permission of Oxford University Press (New York).

Abstract. This essay was commissioned by a group of scholars in bioethics in the

Department of Bioethics at the National Institutes of Health. It picks up the discus-

sionof theBelmontReport roughlywhere I ended the discussion in the first essay. This

second essay further examines the history of the Report together with an explanation

of the National Commissions larger body of publications, which comprised

17 volumes. It discusses the moral content of the principles that were adopted and

the idea that the principles form a basic moral framework for research ethics.

The essay contains a critical evaluation of the philosophical roots of

the principles and includes a section that examines philosophical questions

about and weaknesses in the principles (as they are expressed in the Belmont

Report), including some weaknesses that persist still today in research ethics. The

essay concludes with a section on the influence and ongoing significance of the

Belmont Report, which still stands as an internationally influential government-

commission statement of moral requirements in research ethics. It is possibly

more widely known than any document in research ethics other than the

Declaration of Helsinki, which at present seems to be in a stage of declining

influence. Belmont was eventually adopted by all relevant agencies of the

U.S. government as a statement of the obligations scientific investigators must

discharge in conducting human research. I explain how Belmont has been one of

the few documents to have influenced almost every sphere of activity in

I N T R O D U C T I O N xv

bioethics: moral theory and general standards of professional ethics, government

regulatory activity, bioethics consultation, and even medical practice.

PART II. PRINCIPLISM AND PRACTICE

Essay 3. The Four Principles Approach to Health Care Ethics

Publication Data. This essay was published in Principles of Health Care Ethics, 2nd

ed., Richard Ashcroft, Angus Dawson, Heather Draper, and John Macmillan, eds.

(London: John Wylie, 2007), 310. By permission of Wiley-Blackwell, 9600

Garsington Road, Oxford OX4 2DQ.

Abstract. This essay was first published in the early 1990s with the goal of

explaining and critically examining the four principles or principlist account of

biomedical ethics to an international audience. The first edition of the Principles of

Health Care Ethics was the creation of British physician and medical ethics scholar

Raanan Gillon. This anthology was devoted primarily to critical appraisal of the

Principles book that Childress and I published. My essay on The Four-Principles

Approach was the opening essay in both the first and the second editions. (The

essay is published here as it was revised and updated for the second edition.) The

essay is a basic and reasonably comprehensive explanation of the four-principles

approach, clarifying various of its claims and attempting to straighten out assorted

misunderstandings of the Principles book. The following topics are discussed: the

origins of principled frameworks in bioethics, the nature of the framework that

Childress and I use, the centrality of the common morality in our work, the prima

facie character of principles and rules, the specification of principles and rules, and

the role of the method of coherence in moral justification.

Essay 4. Informed Consent: Its History and Meaning

Publication Data.This essay was published inMedical Ethics, ed. RobertM. Veatch

(Boston and London: Jones and Bartlett Publishers, Inc., 1st edition 1989; 2nd

edition, 1997), 186205. Copyright 1997 Jones and Bartlett Publishers, Sudbury,MA. www.jbpub.com. Reprinted with permission. Some supplementary historical

material has been added that derives from the book I coauthored with Ruth Faden

entitled A History and Theory of Informed Consent (New York: Oxford University

Press, 1986). By permission of Oxford University Press.

Abstract. This essay is a comprehensive treatment of the history, nature, and

moral importance of informed consent. It begins by treating the near absence of

requirements of informed consent in the history of medicine. I trace how

xvi I N T R O D U C T I O N

www.jbpub.com

informed consent obligations and requirements gradually emerged from legal

cases, regulatory interventions, government-appointed commissions, and intra-

professional events in the last half of the twentieth century. Following this history,

I present an analysis of the concept of informed consent, including an analytical

treatment of its basic elements and conceptual conditions. This analysis might

seem to provide a solid foundation for a definition of informed consent, but I

argue that this term needs a deeper analysis. It must be understood in terms of two

common, entrenched, and irreducibly different meanings of informed consent.

I establish the two senses as (1) autonomous choice and (2) institutional consent. I

note that assessment of the quality of the consent is important for understanding

both senses of informed consent and for understanding requirements of

obtaining consent. I argue that the quality of consent should be judged by several

different considerations, including the level of understanding of disclosed infor-

mation and whether undue influence is present in making a request for consent.

Finally, I examine various justifications for waiving or at least not requiring

informed consent. Some are found to be valid reasons for not obtaining consent,

and others are found to be unjustified.

Essay 5. Who Deserves Autonomy and Whose Autonomy Deserves Respect?

Publication Data. This essay was published in Personal Autonomy: New Essays in

Personal Autonomy and Its Role in Contemporary Moral Philosophy, ed. James

Taylor (Cambridge: Cambridge University Press, 2005), 310329. Copyright 2005 Cambridge University Press. Reprinted with the permission of Cambridge

University Press. A few paragraphs of supplementary material have been added

from my Consent and Autonomy, in Frank Miller and Roger Wertheimer, eds.,

The Ethics of Consent (New York: Oxford University Press, 2010). By permission of

Oxford University Press (New York).

Abstract. I distinguish between autonomy, respect for autonomy, and

rights of autonomy.Whereas respect for autonomy and rights of autonomy

are moral notions, autonomy and autonomous person are not obviously

moral notions. To some philosophers they seem metaphysical rather than

moral. However, this distinction between the metaphysical and the moral has

fostered precarious claims in moral philosophy such as these: (1) analysis of

autonomy is a conceptual and metaphysical project, not a moral one; (2) a

theory of autonomy should not be built on moral notions, but rather on a

theory of mind, self, or person; (3) the concept of autonomy is intimately

connected to the concept of person, which alone anchors the concept of moral

status. I assess each of these claims with the objective of determining who qualifies

as autonomous and which level (or degree) of autonomy deserves respect.

I N T R O D U C T I O N xvii

I argue that moral notionsin particular, respect for autonomyshould affect

how we construct theories of autonomous action and the autonomous person on

grounds that a theory of autonomy should be kept consistent with the substantive

assumptions about autonomy implicit in the principle of respect for autonomy.

However, theories of autonomy should only be constrained by the principle of

respect for autonomy, not wholly determined by it. I offer an abbreviated theory of

conceptually necessary conditions of autonomy. My conditions differ substan-

tially from prominent accounts in the literature, such as Harry Frankfurts theory,

which I criticize in section 4 of this paper. My discussion of the claim that the

concept of autonomy is intimately connected to the concept of person leads

directly to the content of essay 14 in these Collected Essays.

Essay 6. The Concept of Paternalism in Biomedical Ethics

Publication Data. This essay was published in the Jahrbuch fur Wissenschaft

und Ethik (2009). Berlin: Walter de Gruyter GmbH & Co. KG; Mies-van-

der-Rohe-Str. 1; 80807 Munchen, Germany. Permission by Rights & Licenses

Department.

Abstract. This essay pulls together in one place the several strands of my thought

over 35 years on the problem of paternalism (principally medical paternalism). In

the literature of biomedical ethics, paternalism has been both defended and

attacked in several areas of clinical medicine, public health, health policy, and

government agency policies (e.g., the policies of the Food and Drug

Administration). I argue that it is unclear in much of this literature what patern-

alism is and which types of paternalism, if any, are justified. The position closest to a

consensus position in the literature is that so-called strong (or hard) paternalism is

not justified, but I argue that strong paternalism can be justified and that it is the

only interesting and controversial form of paternalism. I try to show that questions

of the justification and the definition of paternalism are closely connected, and that

there is a definition that is grounded in fidelity to the principle of respect for

autonomy. I then discuss several of the most prominent practical problems about

paternalism in biomedical ethics. In each case I focus on how obligations of respect

for autonomy and beneficence need to be balanced whenmaking a judgment about

whether a paternalistic intervention is justified.

Essay 7. When Hastened Death Is Neither Killing nor Letting Die

Publication Data. This essay was published in Timothy E. Quill and Margaret

P. Battin, eds., Physician-Assisted Dying: The Case for Palliative Care and Patient

xviii I N T R O D U C T I O N

Choice, pp. 118129. Copyright 2004. The Johns Hopkins University Press.Reprinted with the permission of the Johns Hopkins University Press.

Abstract. This essay covers a broad range of issues in what is today commonly

categorized as physician-assisted suicide. I start with a brief discussion of the recent

history of the issues, from the Quinlan case to the present. I then discuss issues about

rights of autonomous choice, includingwhether the capacity for autonomy is likely to

be reduced in circumstances of making a choice to hasten death and whether

so-called coercive situations sometimes deprive a person of autonomous choice.

I consider the justification of physician involvement in hastening death and whether

the physicians intention makes a morally relevant difference. I also analyze concep-

tual features of the language generally used to discuss these subjects, including

suicide, hastened death, killing, and letting die. These concepts can make a

critical moral difference to how we think about whether an intentionally hastened

death constitutes either a suicide, a killing, or a letting die.

The meaning of these terms also can determine whether suicide, as used both

in medicine and beyond, entails disapproval and whether it is proper to use the

language of causing death, which suggests liability, when characterizing the

physicians action of hastening death. Also assessed are whether the right to die

is a meaningful notion and, if so, how it differs from the right to refuse treatment,

the right to avoid suffering, and the right to death with dignity.

Essay 8. The Exploitation of the Economically Disadvantaged in

Pharmaceutical Research

Publication Data. This essay was published in Denis Arnold, ed., Ethics and the

Business of Biomedicine (Cambridge: Cambridge University Press, 2009).

Copyright 2009 Cambridge University Press. Reprinted with the permissionof Cambridge University Press.

Abstract. I evaluate some searing criticisms of the power and influence of the

pharmaceutical industry that have appeared in various published sources. The

industry stands accused of a sea of injustices and corruptions, including aggressive

and deceptive marketing schemes, exploitative uses of research subjects, a cor-

rupting influence on universities, suppression of and amateurism in handling

scientific data, and conflicts of interest that bias research investigators. Each

charge of injustice derives from concern about some form of unfair influence

exerted by pharmaceutical companies. The array of alleged forms of influence is

vast, and I here telescope to one area: the recruitment and enrollment in clinical

research of vulnerable human subjects, in particular the economically disadvan-

taged. I focus on the charge that subjects in clinical trials are unjustly exploited by

manipulative and unfair payment schemes.

I N T R O D U C T I O N xix

I treat three problems. The first is whether the economically disadvantaged

constitute a vulnerable group. I argue that classification as a group is a misleading

characterization thatmay cause paternalistic overprotection. The second problem is

whether the vulnerable poor are exploited by payments that constitute either an

undue influence or an undue industry profit. I argue that such assessments should

be made situationally, not categorically. The third problem is whether the poor are

likely to give compromised or nonvoluntary consents. I argue that this third

problem, like the second, is subtle and complicated, but practically manageable,

and I add that pharmaceutical research involving the poor and vulnerable can, with

proper precaution, be carried out in an ethically responsible manner. Whether the

research is so conducted is another matter, an empirical problem beyond the scope

of my argument.

PART III. THEORY AND METHOD

Essay 9. Principles and Other Emerging Paradigms in Bioethics

Publication Data. Tom L. Beauchamp, as published in 69 Indiana Law Journal:

117 (1994). Copyright 1994 by the Trustees of Indiana University. Reprintedwith permission. For the present volume I have added a few paragraphs to this

essay.

Abstract. This article is centered on several accounts of biomedical ethics

that allegedly challenge the principles account that Childress and I defend.

Leading critics of our principles (Bernard Gert, Danner Clouser, Albert

Jonsen, Stephen Toulmin, Carson Strong, John Arras, Edmund Pellegrino,

and others) have, since the late 1980s, defended some types of theory or

method proposed as alternatives to or substitutes for principlism. These types

include casuistry, virtue theory, and impartial rule theory. These accounts

were first emerging to prominence in bioethics at the time this article was

written. I welcome these developments in this essay, because they improve

the range, precision, and quality of thought in the field. I also acknowledge

the contribution those who embrace these paradigms have made to the

improvement of my own thought. However, I argue that impartial rule

theory, casuistry, and virtue ethics should not be presented as rivals to

principlism, because they neither replace the principles in principlism nor

are inconsistent with those principles. I argue that all leading alternatives

are compatible with, and not alternatives to, an approach based on princi-

ples. Finally, I point to some limitations of the principle-based approach, in

light of these paradigms, and reflect on how those limitations should be

handled.

xx I N T R O D U C T I O N

Essay 10. A Defense of the Common Morality

Publication Data. This essay was published in Kennedy Institute of Ethics Journal

13:3 (2003): 259274. Copyright 2003. The Johns Hopkins University Press.Reprinted with the permission of the Johns Hopkins University Press.

Abstract. Phenomena of moral conflict and disagreement have led writers in

ethics to two antithetical conclusions: Either moral distinctions hold universally

or they hold only relative to a particular and contingent moral framework. If the

latter, they cannot claim universal validity. In this essay I defend a universalistic

account of the most general norms of morality in the course of responding to

some critics of the common morality theory that Childress and I defend in

Principles. In particular, I respond to criticisms by David DeGrazia and Leigh

Turner, both of whom take common morality to refer to a broader and quite

different body of norms than I do.

I maintain that one can consistently deny universality to some justified moral

norms while claiming universality for others. I argue that universality is located in

the common morality and that nonuniversality is to be expected in other parts of

the moral life, which I call particular moralities. The existence of universal

moral standards is defended in terms of (1) a theory of the objectives of morality,

(2) an account of the norms that achieve those objectives, and (3) an account of

normative justification (both pragmatic and coherentist). This defense in terms of

(1) through (3) sets the stage for the next essay in the volume (#11, as abstracted

immediately below).

Essay 11. From Morality to Common Morality

Publication Data. This essay is forthcoming in a volume to be entitled, roughly,

Bernard Gert and Applied Philosophy. It is being edited at Dartmouth College as

the present volume goes to press. Published by permission of Jim Moor and

Bernard Gert. Abstract. For some 19 years, Bernard Gert has criticized my views about moral

philosophy and the principles of biomedical ethics. In this article I focus on the

major issue addressed in his moral theory: the justification of moralitythat is,

the justification of the common morality. I concentrate on a body of claims that

he and I both defend about the common morality, and I emphasize our simila-

rities rather than our differences. I orient the discussion around his account and

develop my own account in the process.

My objectives in this paper are threefold: first, to argue that the common

morality is a reasonable basis for both moral theory and practical ethics;

I N T R O D U C T I O N xxi

second, to identify and defend three forms of justification of the common

morality; and third, to show precisely where Gert and I agree and disagree. The

main question I address is, Which types of justification of the common morality

are needed, and for which types of claims about the common morality are they

suitable? I present three distinct strategies of justification: (1) normative theore-

tical justification, resting on ethical theory; (2) normative conceptual justification,

resting on conceptual analysis, and (3) empirical justification, resting on empirical

research. Each of these three types justifies a different conclusion about the

common morality. I do not produce a justification of any one of the three

strategies, although I outline the form such justifications would take. That is,

my limited aim is to identify three available types of justification and to identify

the conclusions each type can be expected to reach. In particular, I distinguish

justification of the norms of the commonmorality (Gerts principal project) from

the justification of claims that the common morality exists (which, as yet, is of

little or no interest to Gert, though is of interest to me).

The first half of the paper is devoted to finding points of agreement in our

theories. In the second half, I am critical of Gerts lack of attendance to a few

important issues, especially his neglect of empirical claims, including ones that he

himself seems to rely on. On the whole, this essay presents my account of the

methods of justification of common morality, and therefore is not limited to a

criticism of Gerts views.

Essay 12. On Eliminating the Distinction Between Applied Ethics and

Ethical Theory

Publication Data. This essay was published in The Monist 67 (October 1984):

514531. Copyright The Monist: An International Quarterly Journal of GeneralPhilosophical Inquiry. Open Court Publishing Co., Chicago, Illinois. Reprinted by

permission.

Abstract. I motivate this 1984 paper by noting that so-called applied ethicsa

recently coined termhas become a major growth area in the curricular offerings

in North American philosophy, but that its actual standing in philosophy is

insecure. Many philosophers regard the literature in applied ethics as lightweight

and perhaps philosophically barren. However, I argue that understanding and

teaching the best literature in applied ethics can be as difficult asmasteringmaterial

in more abstract regions of ethical theory, but I also argue that no significant

differences distinguish ethical theory and applied ethics as philosophical activities

or methods. I do not maintain that there are no differences in content. I argue only

that good applied philosophers do what philosophers have always done: They

analyze concepts; submit to critical scrutiny various strategies that are used to

xxii I N T R O D U C T I O N

justify beliefs, policies, and actions; examine hidden presuppositions; and offer

both moral criticism and constructive theories.

Early in the paper I argue for eliminating the distinction between applied ethics

and ethical theory. I turn, in later sections, to methodological considerations,

paying particular attention to the case method and the way analytical argument

surrounds it in law, business, andmedicine. I argue that philosophers can profit in

both a scholarly and a pedagogical way from certain uses of the case method. At

various points in the paper I examine some of the work and the claims of Norman

Daniels, Bernard Gert, and Dan Clouser.

Essay 13. Does Ethical Theory Have a Future in Bioethics?

Publication Data. This essay was published in the Journal of Law, Medicine &

Ethics 32 (2004): 209217. 2004 by the American Society of Law, Medicine &Ethics.

Abstract. This article assesses whether ethical theory is likely to continue in

upcoming years to play the prominent role it has in the previous 25 years of

published literature and curriculum development in bioethics. What transpired

during these years suggests that the field enjoys a successful and stable marriage to

philosophical ethical theory. However, the marriage became shaky as bioethics

became a more interdisciplinary and practical field. A practical price is paid for

theoretical generality in philosophy, and it is not clear that contemporary

bioethics is willing to pay that price. It is also often unclear whether and, if so,

how theory is to be brought to bear on dilemmatic problems, public policy, moral

controversies, and moral conflict. I envision that the next 25 years could be very

different because of this now troubled marriage. The most philosophical parts of

bioethics seem headed toward a retreat to philosophy departments and philo-

sophy journals, while bioethics continues on its current course toward becoming

a more interdisciplinary and practical field.

One piece of evidence of philosophys declining influence is that many individuals

in law, theological ethics, political theory, the social and behavioral sciences, and the

health professions now carefully address mainstream issues of bioethics without

finding ethical theory essential or even particularly useful or insightful. Another is

that philosophers have yet to offer detailed statements of a method for moving from

philosophical theories to the practical commitments of the theories. Although many

moral philosophers are at present actively involved in problems of biomedical ethics

such as clinical and corporate consulting, policy formulation, and committee review,

it is an open question what their role as moral philosophers should be and whether

they can successfully bring ethical theories and methods to bear on problems of

practice.

I N T R O D U C T I O N xxiii

My concerns in this essay are with the types of theory and method that have been

under discussion in bioethics in the last quarter-century. Three interconnected areas

have been prominent: (1) normative moral theories (from utilitarian and Kantian

theories to principlism, casuistry, virtue ethics, feminist ethics, particularism, etc.);

(2) moral and conceptual analyses of basic moral notions (informed consent, the

killing/letting-die distinction, etc.); and (3) methodology (how bioethics

proceedse.g., by use of cases, narratives, specified principles, theory application,

reflective equilibrium, legalmethods, etc.). I leave it an open questionwhether (2) or

(3) can be successfully addressed without addressing (1), an unresolved problem in

philosophical ethics. However, I question philosophys success in all three areas,

laying emphasis on its weaknesses in connecting theory to practice.

In assessing the contemporary literature and how it needs to change, I confine

attention to three substantive areas of the intersection between bioethics and

ethical theory: cultural relativity and moral universality, moral justification, and

conceptual analysis. In each case I argue that philosophers need to develop

theories and methods more closely attuned to practice. The work of several

philosophers, including Ruth Macklin, Norman Daniels, and Gerald Dworkin,

is examined. In their writings there is a methodological gap between philosophical

theory (andmethod) and practical conclusions. The future of philosophical ethics

in interdisciplinary bioethics may turn on whether such gaps can be closed. If not,

bioethics may justifiably conclude that philosophy is of little practical value for

the field.

Essay 14. The Failure of Theories of Personhood

Publication Data. This essay was published in Kennedy Institute of Ethics Journal

9:4 (1999): 309324. Copyright 1999. The Johns Hopkins University Press.Reprinted with the permission of the Johns Hopkins University Press.

Abstract. This article focuses on the pervasive belief in popular culture, philo-

sophy, religion, law, and science (e.g., in research ethics) that some special

property of persons, such as self-consciousness, rationality, language use, or

dignity, confers a unique moral status. I discuss the distinction between moral

persons and metaphysical persons and also the connection or lack of connection

between the theory of autonomy and the theory of persons. I argue that no set of

cognitive properties alone confers moral standing and that metaphysical person-

hood is not sufficient for either moral personhood or moral standing. Cognitive

theories fail to capture the depth of commitments embedded in using the lan-

guage of person, and it is more assumed than demonstrated in cognitive

theories that nonhuman animals lack a relevant form of self-consciousness or

its functional equivalent. Although nonhuman animals are not plausible

xxiv I N T R O D U C T I O N

candidates for moral persons, humans, too, fail to qualify as moral persons if they

lack one or more of the conditions of moral personhood. If moral personhood

were the sole basis of moral rights, then these humans would lack rights for the

same reasons that nonhuman animals are often held to lack rights.

I also argue that the vagueness and the inherently contestable nature of the

concept of person are not likely to be dissipated by philosophical theories of the

nature of persons and that we would be better off if we eliminated the language of

person from moral theory altogether and replaced it with more specific

concepts.

Essay 15. Looking Back and Judging Our Predecessors

Publication Data. This essay was published in Kennedy Institute of Ethics Journal

6:3 (1996): 251270. Copyright 1996. The Johns Hopkins University Press.Reprinted with the permission of the Johns Hopkins University Press.

Abstract. This essay is on the problem of retrospective moral judgment. It

considers how moral theory and related methods of assessment should be used

to address the following question: Can persons and institutions be held respon-

sible for actions taken decades ago, when moral standards, practices, and policies

were strikingly different, or even nonexistent? The question is whether the

principles and rules that we currently embrace are unfairly retrofitted when we

use them to make judgments about the medical ethics of our predecessors. This

seemingly straightforward question requires making several distinctions and

using different forms of argument to untangle the issue(s). For example, issues

of wrongdoing need to be disengaged from questions of culpability and exculpa-

tion. Also, even if institutions can be found guilty of wrongdoing, it does not

follow that particular individuals in those institutions can be found to be either

wrongdoers or culpable.

To illustrate the problems of theory and method present in these questions,

I consider two morally and politically important examples of how these ques-

tions have arisen in biomedical ethics. Both come from research ethics, and the

two are intimately connected. The first source is a set of moral problems

addressed in the Report of the Advisory Committee on Human Radiation

Experiments that was appointed by President William Clinton to investigate

questionable experiments funded by the U.S. government after World War II.

The second is the work of an Ad Hoc faculty committee at the University of

California, San Francisco (Report of the UCSF Ad Hoc Fact Finding

Committee on World War II Human Radiation Experiments) that investi-

gated the ethics of the actions of its own administration and faculty in its

involvement in the human radiation experiments.

I N T R O D U C T I O N xxv

The Advisory Committee identified six basic ethical principles as relevant to its

work and then appropriately argued that persons and institutions can be held

responsible for actions taken even if the standards, practices, and policies at the

time on the use of research subjects were strikingly different than those we call

upon today. I argue that in reaching its conclusions, the Advisory Committee

did not altogether adhere to the language and commitments of its own ethical

framework. In its Final Report, the Advisory Committee emphasizes judgments of

wrongdoing, to the relative neglect of culpability; I argue that the Advisory

Committee properly treats mitigating conditions that are exculpatory, but does

not provide a thoroughgoing assessment of either culpability or exculpation.

It also fails to judge the culpability of particular individuals, though it was

positioned to do so.

I am thus critical of the Advisory Committees findings, but I am especially critical

of the more serious deficiencies in the Ad Hoc Committees deliberations and

conclusions. The latter group reaches no significant judgments of either wrongdoing

or culpability, but almost certainly should have. A balanced investigation would have

more critically assessed (1) physician wrongdoing, (2) the culpability of specific

agents, and (3) institutional responsibility.

xxvi I N T R O D U C T I O N

Part I

THE BELMONT REPORT AND THE RISE OF

PRINCIPLES

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1

THE ORIGINS AND EVOLUTION OF THE

BELMONT REPORT

When, onDecember 22, 1976, I agreed to join the staff of theNationalCommission for

the Protection of Human Subjects of Biomedical and Behavioral Research, my first

and onlymajor assignment was towrite the Belmont Paper, as it was then called. At

the time, I had already drafted substantial parts of Principles of Biomedical Ethicswith

James Childress.1 Subsequent to my appointment, the two manuscripts were drafted

simultaneously, often side by side, the one inevitably influencing the other.

I here explain how the Belmont Paper evolved into the Belmont Report.2 I will

also correct some common but mistaken speculation about the emergence of

frameworks of principles in research ethics and the connections between Belmont

and Principles.

THE BEGINNINGS OF BELMONT

The idea for the Belmont Paper originally grew from a vision of shared moral

principles governing research that emerged during a break-out session at a four-

day retreat held February 1316, 1976, at the Smithsonian Institutions Belmont

Conference Center in Maryland.3 Albert Jonsen has reported on the contributions

at this meeting of Stephen Toulmin, Karen Lebacqz, Joe Brady, and others.4

However, this meeting predates my work on the Belmont Report, and I leave it

to Jonsen and the others in attendance to relate the story of the retreat.

A few months after this conference at Belmont, I received two phone calls: the

first fromToulmin, whowas the staff philosopher at the National Commission, and

the second from Michael Yesley, staff director. They asked me to write a paper for

the National Commission on the nature and scope of the notion of justice. Yesley

told me that the commissioners sought help in understanding theories of justice

and their applications to themoral problems of human subject research. I wrote this

paper and assumed that my work for the National Commission was concluded.5

However, shortly after I completed the paper, Toulmin returned to full-time

teaching at the University of Chicago, and Yesley inquired whether I was available

to replace him on the staff. This appointment met some resistance. Two commis-

sioners who later became my close friendsBrady and Donald Seldinwere

initially skeptical of the appointment. Nonetheless, Yesley prevailed, likely with

the help of Chairperson Kenneth Ryan and my colleague Patricia King, and

I joined the National Commission staff.

On my first morning in the office, Yesley told me that he was assigning me the

task of writing the Belmont Paper.6 I asked Yesley what the task was. He pointed

out that the National Commission had been charged by Congress to investigate

the ethics of research and to explore basic ethical principles.7Members of the staff

were at work on various topics in research ethics, he reported, but no one was

working on basic principles. He said that an opening round of discussions of the

principles had been held at the Belmont retreat. The National Commission had

delineated a rough schema of three basic ethical principles: respect for persons,

beneficence, and justice. I asked Yesley what these moral notions meant to the

commissioners, to which he responded that he had no well-formed idea and that

it was my job to figure out what the commissioners meantor, more likely, to

figure out what they should have meant.

So, I found myself with the job of giving shape and substance to something

called the Belmont Paper, though at that point I had never heard of Belmont or

the paper. It struck me as an odd title for a publication. Moreover, this document

had never been mentioned during my interview for the job or at any other time

until Yesley gave me the assignment. My immediate sense was that I was the new

kid on the block and had been given the dregs of National Commission work.

I had thought, when I decided to join the National Commission staff, that I would

be working on the ethics of psychosurgery and research involving children, which

were heated and perplexing controversies at the time. I was chagrined to learn that

I was to write something on which no one else was working and that had its

origins in a retreat that I had not attended. Moreover, the mandate to do the work

had its roots in a federal law that I had not seen until that morning.

Yesley proceeded to explain that no one had yet worked seriously on the

sections of the report on principles because no one knew what to do with them.

This moment of honesty was not heartening, but I was not discouraged either,

4 T H E B E L M O N T R E P O R T A N D T H E R I S E O F P R I N C I P L E S

because Childress and I were at that time well into the writing of our book on the

role of basic principles in biomedical ethics. It intrigued me that the two of us had

worked relatively little on research ethics, which was the sole focus of the National

Commission. I saw in my early conversations with Yesley that these two projects,

Principles and Belmont, had many points of intersecting interest and could be

mutually beneficial. And so it would be.

Yesley also gave me some hope by saying that a crude draft of the Belmont

Paper already existed, though a twinkle in his eye warned me not to expect too

much. That same morning I read the Belmont draft.8 Scarce could a new recruit

have been more dismayed. So little was said about the principles that to call it a

draft of principles would be like calling a dictionary entry a scholarly treatise.

Some sections were useful, especially a few handsome pages that had been written

largely by Robert Levine on the subject of The Boundaries Between Biomedical

and Behavioral Research and Accepted and Routine Practice (later revised under

the subtitle Boundaries Between Practice and Research and made the first

section of the Belmont Report). Apart from Levines contribution, however, this

draft of Belmont had almost nothing to say about the principles that were slated to

be its heart.

In the next few weeks, virtually everything in this draft pertaining to principles

would be thrown away either because it contained too little on principles or

because it had too much on peripheral issues. At the time, these peripheral issues

constituted almost the entire document, with the exception of the section written

by Levine, which was neither peripheral nor on principles. The major topics

addressed were the National Commissions mandate, appropriate review

mechanisms, compensation for injury, national and international regulations

and codes, research design, and other items that did not belong in the Belmont

Report. These topics, being peripheral, were therefore eliminated. Except for

Levines section on boundaries, everything in this draft landed on the cutting-

room floor.9

Once the Belmont draft was left with nothing in the section on principles,

Yesley suggested that I might find the needed content from the massive compen-

dium on research titled Experimentation with Human Beings, edited by Jay Katz

with the assistance of Alexander Capron and Eleanor Swift Glass.10 Drawn from

sociology, psychology, medicine, and law, this book was at the time the most

thorough collection of materials on research ethics and law. Yesley informed me

that I should endeavor to learn all the information presented in this book, but

after days of poring over this wonderful resource, I found that it offered virtually

nothing on principles suitable for an analytical discussion of research ethics. The

various codes and statements by professional associations found in this book had

occasional connections with my task and with the National Commissions objec-

tives, but only distant ones.11

T H E O R I G I N S A N D E V O L U T I O N O F T H E B E L M O N T R E P O R T 5

THE HISTORICAL ORIGINS OF THE PRINCIPLES

OF THE BELMONT REPORT

Fortunately, Childress and I had gathered a useful collection of materials on

principles and theories, largely in the writings of philosophers. I had been

influenced in my thinking about principles by the writings of W. D. Ross and

William Frankena. My training led me to turn to these and other philosophical

treatments, which had already proved helpful in my work on Principles.

However, it would be misleading to suggest that the principles featured in the

Belmont Report derived from the writings of philosophers. Their grounding is

ultimately in what I would eventually call, following Alan Donagan, the common

morality. The Belmont Report makes reference to our cultural tradition as the

basis of its principles, and it is clear that these principles derive from the common

morality rather than a particular philosophical work or tradition. However, what

Belmont means by our tradition is unclear, and I believe the import of the

Belmont principles cannot be tied to a particular tradition, but rather to a

conviction that there is a universally valid point of view. I believe, and I think

that the commissioners believed, that these principles are norms shared by all

morally informed and committed persons.

The commissioners almost certainly believed that these principles are already

embedded in public morality and are presupposed in the formulation of public and

institutional policies. The principles do not deviate from what every morally sensi-

tive personknows tobe right, based onhis orher ownmoral training and experience.

That is, every morally sensitive person believes that a moral way of life requires that

we respect persons and take into account their well-being in our actions. Belmonts

principles are so woven into the fabric of morality that no responsible research

investigator could conduct research without reference to them.12

THE RELATIONSHIP BETWEEN THE BELMONT PRINCIPLES AND THE

PRINCIPLES IN PRINCIPLES OF BIOMEDICAL ETHICS

Many have supposed that the Belmont Report provided the starting point and the

abstract framework for Principles of Biomedical Ethics.13 They have wrongly

assumed that Belmont preceded and grounded Principles.14 The two works were

written simultaneously, the one influencing the other.15 There was reciprocity in

the drafting, and influence ran bilaterally. I was often simultaneously drafting

material on the same principle or topic both for the National Commission and for

my colleague Childress, while he was at the same time writing material for me to

inspect. I would routinely write parts of the Belmont Report during the day at the

National Commission headquarters on Westbard Avenue in Bethesda, then go to

6 T H E B E L M O N T R E P O R T A N D T H E R I S E O F P R I N C I P L E S

my office at Georgetown University in the evening and draft parts of chapters for

Childress to review. Despite their entirely independent origins, these projects

grew up and matured together.

Once I grasped the moral vision the National Commission initiated at Belmont, I

could see thatChildress and I hadmajor substantive disagreementswith theNational

Commission. The names of the principles articulated in the Belmont Report bear

notable similarities to some of the names Childress and I were using and continued

to use, but the two schemas of principles are far from constituting a uniform name,

number, or conception. Indeed, the two frameworks are inconsistent.

I regarded the National Commission as confused in the way it analyzed the

principle of respect for persons. It seemed to blend a principle of respect for

autonomy and a principle of beneficence that required protection of, and avoidance

of the causation of harm to, incompetent persons. Childress and I both thought at

the time that we should make our analysis turn on sharp distinctions between the

principle of beneficence, the principle of nonmaleficence, and the principle of

respect for autonomy, though the National Commission did not make such sharp

distinctions. This matter was connected to an additional problem: The National

Commission may have had a fundamentally utilitarian vision of social beneficence

without adequate internal controls in its framework toprotect subjects against abuse

when there is the promise of major benefit for other sick or disabled persons.

The differences between the philosophy in Principles and the National

Commissions views in Belmont have occasionally been the subject of published

commentary.16 Some commentators correctly see that we developed substantially

different moral visions and that neither approach was erected on the foundations

of the other. By early 1977, I had come to the view that the National Commission,

especially in the person of its chair, Kenneth Ryan, was sufficiently rigid in its

vision of the principles that there was no way to substantively alter the conception,

although I thought that all three principles were either defective or underanalyzed.

From this point forward, I attempted to analyze principles for the National

Commission exclusively as the commissioners envisioned them. Principles of

Biomedical Ethics became the sole work expressing my deepest philosophical

convictions about principles.

THE DRAFTING AND REDRAFTING OF BELMONT

While Yesley gave me free rein in the drafting and redrafting of Belmont, the drafts

were always subject to revisions and improvements made by the commissioners and

staff members.17 All members of the staff did their best to formulate ideas that were

responsive to changes suggestedby the commissioners.Commissioner Seldin encour-

aged me with as much vigor as he could muster, which was and remains today

T H E O R I G I N S A N D E V O L U T I O N O F T H E B E L M O N T R E P O R T 7

considerable, to make my drafts as philosophical as possible. Seldin wanted some

Mill here, some Kant there, and the signature of philosophical argument sprinkled

throughout the document. I tried this style, but other commissioners wanted a

streamlined document and minimalist statement relatively free of the trappings of

philosophy. Seldin, Yesley, and I ultimately relented,18 and bolder philosophical

defenses of the principles were gradually stripped from the body of Belmont.

Public deliberations in National Commission meetings were a staple source of

ideas, but a few commissioners spoke privately to me or to Yesley about desired

changes, and a few commissioners proposed changes to Assistant Staff Director

Barbara Mishkin, who then passed them on to me. Most of these suggestions were

accepted, and a serious attempt was made to implement them. In this respect, the

writing of this document was a joint product of commissionerstaff interactions.

However, most of the revisions made by the commissioners, other than through

their comments in public deliberations, concerned small matters, and the commis-

sioners were rarely involved in tendering written changes or detailed suggestions.

An exception to this generalization is found in a meeting on Belmont involving

a few members of the staff and a few commissioners that occurred during

September 1977 in the belvedere (or rooftop study) of Jonsens home in San

Francisco. The small group in attendance attempted to revise the Belmont

Paper for presentation at the next meetings during which the commissioners

were scheduled to debate it. As Jonsen reports in The Birth of Bioethics and

elsewhere, the purpose of this meeting was to revisit previous drafts and delibera-

tions of the commissioners.19

The history of drafting and redrafting that I have outlined may suggest that the

document grew in size over time, but the reverse is true. The document grew

quickly in the early drafting and then was contracted over time. I wrote much

more for the National Commission about respect for persons, beneficence, and

justice than eventually found its way into the Belmont Report. When various

materials I had written were eliminated from Belmont, I would scoop up the

reject piles and fashion them for Principles of Biomedical Ethics. Several late-

written chunks of this book, in its parts on research ethics, were fashioned from

the more philosophical but abjured parts of what I wrote for the National

Commission that never found their way into the final draft of Belmont.

EXPLICIT AND IMPLICIT IDEAS ABOUT AN APPLIED RESEARCH ETHICS

Michael Yesley deserves credit for one key organizing conception in this report.

He and I were in almost daily discussion about the Belmont Paper. We spent

many hours discussing the best way to develop the principles to express what the

commissioners wanted to say, and even how to sneak in certain lines of thought

8 T H E B E L M O N T R E P O R T A N D T H E R I S E O F P R I N C I P L E S

that the commissioners might not notice. One late afternoon we were discussing

the overall enterprise. We discussed each principle, whether the principles were

truly independent, and how the principles related to the topics in research ethics

under consideration by the National Commission. Yesley said, as a way of

summarizing our reflections, What these principles come to is really quite

simple for our purposes: Respect for persons applies to informed consent, ben-

eficence applies to risk-benefit assessment, and justice applies to the selection of

subjects. Yesley had articulated the following abstract schema:

This schema may seem trifling today, and it was already nascent in preexisting

drafts of the report and in the National Commissions deliberations. But no one at

the time had articulated these ideas in precisely this way, and Yesleys summary

was immensely helpful in peering through countless hours of discussion to see the

underlying structure and commitment at work in the principles destined to be the

backbone of Belmont. Yesley had captured what would soon become the major

portion of the table of contents of the Belmont Report, as well as the rationale of its

organization. I then attempted to draft the document so that the basic principles

could be applied to develop guidelines in specific areas and could also serve as

justification for guidelines.

In light of this schema, a general strategy emerged for handling problems of

research ethics, namely, that each principle made moral demands in a specific

domain of responsibility for research. For example, the principle of respect for

persons demands informed and voluntary consent. Under this conception, the

purpose of consent provisions is not protection from risk, as many earlier federal

policies seemed to imply, but the protection of autonomy and personal dignity,

including the personal dignity of incompetent persons incapable of acting auton-

omously, for whose involvement a duly authorized third party must consent.

I wrote the sections on principles in the Belmont Report based on this model of

each principle applying to a zone of moral concern. In this drafting, the focus of

the document shifted to include not only abstract principles and their analysis,

but also a moral view that is considerably more concrete andmeaningful for those

engaged in the practice of research. Explication of the value being advanced was

heavily influenced by the context of biomedicine, and rather less influenced by

contexts of the social and behavioral sciences. Belmont, in this way, moved toward

an applied, professional morality of research ethics.

Principle of Applies to Guidelines for

Respect for persons Informed consent

Beneficence Riskbenefit assessment

Justice Selection of subjects

T H E O R I G I N S A N D E V O L U T I O N O F T H E B E L M O N T R E P O R T 9

Although Belmont takes this modest step in the direction of an applied research

ethics, there was never any ambition or attempt to make this document specific

and practical. This objective was to be accomplished by the other volumes the

National Commission issued. Belmont was meant to be, and should be remem-

bered as, a moral framework for research ethics. Commissioners and staff were

always aware that this framework is too indeterminate by itself to decide practice

or policy or to resolve moral conflicts. The process of making the general

principles in Belmont sufficiently concrete is a progressive process of reducing

the indeterminateness and abstractness of the general principles to give them

increased action-guiding capacity.20 Belmont looks to educational institutions,

professional associations, government agencies, institutional review boards, and

the like to provide the particulars of research ethics.

PRINCIPLISM, CASUISTRY, OR BOTH?

Another misunderstanding of both Principles and Belmont has emerged in recent

treatments of casuistry. Some commentators have misinterpreted the National

Commissions work by overreading it as fundamentally a casuistry, and other

commentators have misinterpreted Principles of Biomedical Ethics by under-

reading it as competitive with, and possibly undermined by, casuistry. However,

a better interpretation is available: The National Commission demonstrably used

casuistical reasoning in its deliberations, but its commitment to basic principles

was never challenged throughout its years of deliberation. Similarly, Childress and

I have from our first edition used casuistical reasoning in the treatment of cases,

and we do not believe that there is any inconsistency between this form of

reasoning and a commitment to principles. In the histories of both the National

Commission and Principles of Biomedical Ethics, it is difficult to understand how

the two commitments could be seen as other than complementary.

The final editing of the Belmont Report was done by three people in a small

classroom at the NIH.21 Al Jonsen, Stephen Toulmin, and I were given this assign-

ment by the National Commission. Some who have followed the later writings of

Jonsen and Toulmin on casuistry may be surprised to learn that throughout the

National Commissions deliberations, as well as in this final drafting, Jonsen and

Toulmin contributed to the clarification of the principles in the report. There was

never an objection by either that a strategy of using principles should be other than

central to the National Commissions statement of its ethical framework. Jonsen has

often repeated his support for these principles.

However, Jonsen has also said that commissioners stated their views as

principlists, but deliberated as casuists. He is suggesting that the National

Commissions deliberations constituted a casuistry of reasoning about historical

10 T H E B E L M O N T R E P O R T A N D T H E R I S E O F P R I N C I P L E S

and contemporary cases,22 despite the commissioners commitment to and frequent

reference to the Belmont principles. Jonsen and Toulmin once explicated this under-

standingof theNationalCommissionswork in termsof the individual commissioners

coming to agreement not on matters of moral theory and universal principles, but

rather onhow tomake judgments about specific kinds of cases. Agreement, they argue,

could never have been derived from the principles.23

This interpretation gives insight into theNational Commission, but it needs careful

qualification to avoid misunderstanding. Casuistical reasoning more so than moral

theory or universal abstraction often did function to forge agreement duringNational

Commission deliberations. The commissioners appealed to particular cases and

families of cases, and consensuswas reached through agreement on cases and general-

ization from cases when agreement on an underlying theoretical rationale would have

been impossible.24 Commissioners would never have been able to agree on a single

ethical theory, nor did they even attempt to buttress the Belmont principles with a

theory. Jonsen andToulmins treatment of theNationalCommission is, in this regard,

entirely reasonable, and a similar line of argument can be taken to explicate the

methods of reasoning at work in other bioethics commissions.25

Nonetheless, thismethodological appraisal is consistent with a firm commitment

to moral principles; the commissioners, including Jonsen, were emphatic in their

support of and appeals to the general moral principles delineated in the Belmont

Report.26 The transcripts of the National Commissions deliberations show a con-

stant movement from principle to case and from case to principle. Principles

supported arguments about how to handle a case, and precedent cases supported

the importance of commitment to principles. Cases or examples favorable to one

point of view were brought forward, and counterexamples then advanced.

Principles were invoked to justify the choice and use of both examples and counter-

examples. On many occasions an argument was offered that a case judgment was

irrelevant or immoral in light of the commitments of a principle.27 The National

Commissions deliberations and conclusions are best understood in terms of

reasoning in which principles are interpreted and specified by the force of examples

and counterexamples that emerge from experience with cases.

It is doubtful that Jonsen ever intended to deny this understanding of principles

and their roles, despite the widely held view that casuistry dispenses with principles.

Jonsen has said that casuistic analysis does not deny the relevance of principle and

theory,28 and, in an insightful statement in his later work, he has written that:

when maxims such as Do no harm, or Informed consent is obligatory, are

invoked, they represent, as it were, cut-down versions of the major principles

relevant to the topic, such as beneficence and autonomy, cut down to fit the

nature of the topic and the kinds of circumstances that pertain to it.29

T H E O R I G I N S A N D E V O L U T I O N O F T H E B E L M O N T R E P O R T 11

Jonsen goes on to point out that casuistry is complementary to principles and

that casuistry is not an alternative to principles: No sound casuistry can dispense

with principles.30

Casuists and those who support frameworks of principles like those in Belmont

and Principles of Biomedical Ethics should be able to agree that when they reflect

on cases and policies, they rarely have in hand either principles that were for-

mulated without reference to experience with cases or paradigm cases lacking a

prior commitment to general norms. Only a false dilemma makes us choose

between the National Commission as principlist or casuist. It was both.

Notes

1. A contract for the book was issued by Oxford University Press on August 19, 1976. The

manuscript was completed in late 1977; galleys arrived in October 1978, bearing the 1979

copyright date.

2. See also Appendices I and II to the Belmont Report. The Belmont Reportwas completed

in late 1977 and published on September 30, 1978: The Belmont Report: Ethical Guidelines for

the Protection of Human Subjects of Research (Washington, DC: DHEW Publication OS

78-0012). It first appeared in the Federal Register on April 18, 1979.

The National Commission for the Protection of Human Subjects of Biomedical and

Behavioral Research was established July 12, 1974, under the National Research Act, Public

Law 93-348, Title II. The first meeting was held December 34, 1974. The 43rd and final

meeting was on September 8, 1978.

3. See the archives of the National Commission, 15th meeting, February 1316, 1976, vol.

15Aa volume prepared for the Belmont meeting. This meeting book contains a staff

summary on the subject of ethical principles as well as expert papers prepared by Kurt

Baier, Alasdair Maclntyre, James Childress, H. Tristram Engelhardt, Alvan Feinstein, and

LeRoy Walters. The papers by Engelhardt andWalters most closely approximate the moral

considerations ultimately treated in the Belmont Paper, but neither quite matches the

National Commissions three principles. Walters, however, comes very close to a formula-

tion of the concerns in practical ethics to which the National Commission applies its

principles. All meeting books are housed in the archives of the Kennedy Institute of Ethics

Library, Georgetown University.

4. On the Origins and Future of the Belmont Report, in Belmont Revisited: Ethical

Principles for Research, ed. James F. Childress, Eric M. Meslin, and Harold T. Shapiro

(Washington, DC: Georgetown University Press, 2005), 311.

5. The paper was published as Distributive Justice and Morally Relevant Differences,

in Appendix I to the Belmont Report, 6.16.20. This paper was distributed at the 22nd

meeting of the National Commission, held in September 1976, seven months after the

retreat at the Belmont Conference House.

6. My first day in attendance at a National Commission meeting was the Saturday

meeting of the National Commission on January 8, 1977.

12 T H E B E L M O N T R E P O R T A N D T H E R I S E O F P R I N C I P L E S

7. The National Research Act, P.L. 93-348, July 12, 1974. Congress charged the National

Commission with recommending regulations to the Department of Health, Education, and

Welfare (DHEW) to protect the rights of research subjects and developing ethical princi-

ples to govern the conduct of research. In this respect, the Belmont Report was at the core of

the tasks the National Commission had been assigned by Congress. DHEWs conversion of

its grants administration policies governing the conduct of research involving human

subjects into formal regulations applicable to the entire department was relevant to the

creation of the National Commission. In the U.S. Senate, Senator Edward Kennedy, with

Jacob Javitss support, was calling for a permanent, regulatory commission independent of

the National Institutes of Health (NIH) to protect the welfare and rights of human subjects.

Paul Rogers in the House supported the NIH in advocating that the commission be

advisory only. Kennedy agreed to yield to Rogers if DHEW published satisfactory regula-

tions. This compromise was accepted. Regulations were published on May 30, 1974; then,

on July 12, 1974, P.L. 93-348 was modified to authorize the National Commission as an

advisory body. Charles McCarthy helped me understand this history. For a useful framing

of the more general regulatory history, see Joseph V. Brady and Albert R. Jonsen (two

commissioners), The Evolution of Regulatory Influences on Research with Human

Subjects, in Human Subjects Research, ed. Robert Greenwald, Mary Kay Ryan, and

James E. Mulvihill, (New York: Plenum Press, 1982), 318.

8. This draft had a history beginning with the 16th meeting (March 1214, 1976), which

contained a draft datedMarch 1, 1976, and titled Identification of Basic Ethical Principles.

This document summarized the relevant historical background and set forth the three

underlying ethical principles that came to form the National Commissions framework.

Each principle was discussed in a single paragraph. This document was slightly recast in a

draft of June 3, 1976 (prepared for the ninth meeting, June 1113, 1976), in which the

discussion of principles was shortened to little more than one page devoted to all three

principles. Surprisingly, in the summary statement (p. 9), respect for persons is presented

as the principle of autonomy. No further draft was presented to the National

Commission until ten months later, at the 29th meeting (April 89, 1977). I began work

on the document in January 1977.

Transcripts of the National Commissions meetings are also available in the archives of

the Kennedy Institute of Ethics at Georgetown University. See National Commission for

the Protection of Human Subjects of Biomedical and Behavioral Research. Archived

Materials 197478, General Category: Transcript of the Meeting Proceedings (for discus-

sion of the Belmont Paper at the following meetings: February 1113, 1977; July 89, 1977;

April 1415, 1978; and June 910, 1978).

9. Cf. the radical differences between the draft available at the 19th meeting (June 113,

1976) and the draft at the 29th meeting (April 89, 1977). The drafts show that the critical

period that gave shape to the Belmont principles was the period between January and April

1977. Less dramatic improvements were made between April 1977 and eventual publication

more than a year later.

10. Jay Katz, with the assistance of Alexander Capron and Eleanor Glass, eds.,

Experimentation with Human Beings (New York: Russell Sage Foundation, 1972).

T H E O R I G I N S A N D E V O L U T I O N O F T H E B E L M O N T R E P O R T 13

11. The first and only footnote in the Belmont Report is a reference to this background